Pacemaker DDDLEAD-LBBPNCT06318130
Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes: The LEAD_LBBP Randomized Clinical Trial
A study testing Fixed helix, lumenless pacing lead. and Extendable helix, stylet-driven pacing lead. in people with Pacemaker DDD, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
This trial seeks to evaluate the performance of the extendable helix, stylet-driven pacing lead (SDL) compared to the fixed helix, lumenless pacing lead (LLL) during left bundle branch pacing (LBBP), with respect to enduring left bundle branch capture on follow-up, incidence of acute lead failure, pacing… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pacemaker DDD
- What is being tested?
- Fixed helix, lumenless pacing lead. and Extendable helix, stylet-driven pacing lead.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jan 2023to 19 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fulfil current indications for pacemaker therapy according to international guideline recommendations:
- Symptomatic sinus bradycardia/sinus node dysfunction or AV block requiring pacemaker insertion.
- Symptomatic heart failure, left ventricular ejection fraction (LVEF) <35%, left bundle branch block and QRS duration >120ms.
- Symptomatic heart failure, left ventricular ejection fraction (LVEF) <35%, right bundle branch block and QRS duration >150ms.
- LVEF <50% with significant anticipated ventricular pacing requirement of ≥20%.
- Age ≥21 years old
- Able to provide informed consent
- Planned LBBP implantation
Who cannot join
- Severe tricuspid regurgitation or previous tricuspid valve intervention requiring implantation of left ventricular lead in the coronary sinus.
- Unable to provide informed consent.
- Pregnant women.
- <21 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes
This trial seeks to evaluate the performance of the extendable helix, stylet-driven pacing lead (SDL) compared to the fixed helix, lumenless pacing lead (LLL) during left bundle branch pacing (LBBP), with respect to enduring left bundle branch capture on follow-up, incidence of acute lead failure, pacing characteristics including QRS duration, pacing thresholds, R-wave amplitudes and lead impedance, and finally, safety profile during LBBP implantation. These data will guide future lead selection during LBBP implantation in achieving improved procedural success and optimal lead performance.
Read the detailed description
This study is a single-blind, randomised controlled trial, aimed at evaluating the performance of the extendable helix, stylet driven pacing lead (SDL) compared to the fixed helix, lumenless pacing lead (LLL) during left bundle branch pacing (LBBP). The study is a multicentre study across 3 major hospitals in Singapore, and LBBP performed by independent electrophysiologists experienced in performing LBBP.
The primary objective of the study is to determine differences in incidence of loss of left bundle capture by pacing lead design (LLL vs SDL). The secondary objectives are to determine if lead design affects frequency of lead failure during implantation, investigate differences in short- and medium-term LBBP parameters on follow-up by lead design, and evaluate differences in safety profile between LLL and SDL in LBBP.
This study aims to recruit a target of 210 patients. A previous retrospective study found a loss of LB capture rate of 9% with LLL and 25% with SDL. A sample size of 170 will be required for a type-1 error rate of 5% and power of 80%. Accounting for a dropout rate of 20%, a total of 210 patients will be recruited (105 per group). Eligible subjects will be randomised to either the LLL or the SDL arm. The randomisation list will be generated with a computer-generated sequence in permuted blocks of 4, stratified by centre, to ensure a final allocation ratio of 1:1.
- Conditions
- Pacemaker DDD
- Being tested
- Fixed helix, lumenless pacing lead., Extendable helix, stylet-driven pacing lead.
- Keywords
- Left bundle branch pacing, Lead design, Conduction system pacing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed helix, lumenless pacing lead.Device
Patients will be randomised to the fixed helix, lumenless pacing lead design during LBBP implantation.
Extendable helix, stylet-driven pacing lead.Device
Patients will be randomised to the extendable helix, stylet-driven pacing lead design during LBBP implantation.
| Study group | Role | What they receive |
|---|---|---|
| Fixed helix, lumenless pacing lead (FHL) | Active comparator | Lumenless leads used are fixed helix pacing leads (SelectSecure 3830 pacing lead from Medtronic) during the LBBP procedure. Receives: Device: Fixed helix, lumenless pacing lead. |
| Extendable helix, stylet-driven leads (EHL) | Active comparator | Stylet-driven leads used are extendable helix pacing leads (Biotronik Solia S60 lead from Biotronik or Tendril STS pacing lead from St. Jude Medical) during the LBBP procedure. Receives: Device: Extendable helix, stylet-driven pacing lead. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of loss of left bundle branch capture
Loss of LBB capture is defined as the absence of the terminal r/R' complex in V1 during initial threshold interrogations at high pacing outputs and the absence of transitions in paced QRS morphology with decreasing pacing outputs until loss of myocardial capture.
Measured: 12 months
Secondary outcomes (6)
Incidence of acute lead failure
Acute lead failure is defined as defined as structural damage to the pacing lead during implant necessitating the use of a new pacing lead.
Measured: 12 months
Serial changes in pacing thresholds (V)
To compare the differences in pacing thresholds (V) at implant and at 12 months after LBBP implant.
Measured: 12 months
Serial changes in R-wave amplitude (mV)
To compare the differences in R-wave amplitude (mV) at implant and at 12 months after LBBP implant.
Measured: 12 months
Serial changes in lead impedance (ohm)
To compare the differences in lead impedance (ohm) at implant and at 12 months after LBBP implant.
Measured: 12 months
Serial changes in QRS duration (ms)
To compare the differences in QRS duration (ms) at implant and at 12 months after LBBP implant.
Measured: 12 months
Incidence of peri-procedural complications
Complications intraprocedurally and on follow-up will be evaluated, including lead dislodgement, lead fracture during implant, septal perforation, septal vein/arterial injury, pneumothorax, pericardial effusion, wound/pacemaker infection.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Jan 2023
- Primary completion19 Oct 2025 (estimated)
- Study completion19 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pacemaker DDDStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A target of 210 participants will be enrolled in this study consisting of two groups and randomised in a 1:1 fashion to either of two groups. Group 1: Fixed helix, lumenless pacing lead (FHL) Group 2: Extendable helix, stylet driven pacing lead (EHL)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eugene Tan, MBBS, Principal investigator, NUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318130
- Sponsor's protocol ID
- LEAD-LBBP
- Acronym
- LEAD-LBBP
- Status last verified
- May 2025
- First submitted
- 6 Feb 2024
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tan ESJ, Soh R, Lee JY, Yip A, Sim MA, Chan SP, Reymatias J, Boey E, Tan VH, Yeo C, Lim WY, Leong K, Yeo WT, Seow SC, Kojodjojo P. Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes: LEAD-LBBP Randomized Clinical Trial. JACC Clin Electrophysiol. 2026 Jun 27:S2405-500X(26)00556-6. doi: 10.1016/j.jacep.2026.06.008. Online ahead of print.
PubMed 42429724
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes
- ClinicalTrials.gov ID
- NCT06318130
- Acronym / sponsor ID
- LEAD-LBBP / LEAD-LBBP
- Conditions
- Pacemaker DDD
- Keywords
- Left bundle branch pacing, Lead design, Conduction system pacing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 19 Oct 2025 (estimated)
- Study completion
- 19 Oct 2025 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial seeks to evaluate the performance of the extendable helix, stylet-driven pacing lead (SDL) compared to the fixed helix, lumenless pacing lead (LLL) during left bundle branch pacing (LBBP), with respect to enduring left bundle branch capture on follow-up, incidence of acute lead failure, pacing characteristics including QRS duration, pacing thresholds, R-wave amplitudes and lead impedance, and finally, safety profile during LBBP implantation. These data will guide future lead selection during LBBP implantation in achieving improved procedural success and optimal lead performance.
Detailed description
This study is a single-blind, randomised controlled trial, aimed at evaluating the performance of the extendable helix, stylet driven pacing lead (SDL) compared to the fixed helix, lumenless pacing lead (LLL) during left bundle branch pacing (LBBP). The study is a multicentre study across 3 major hospitals in Singapore, and LBBP performed by independent electrophysiologists experienced in performing LBBP.
The primary objective of the study is to determine differences in incidence of loss of left bundle capture by pacing lead design (LLL vs SDL). The secondary objectives are to determine if lead design affects frequency of lead failure during implantation, investigate differences in short- and medium-term LBBP parameters on follow-up by lead design, and evaluate differences in safety profile between LLL and SDL in LBBP.
This study aims to recruit a target of 210 patients. A previous retrospective study found a loss of LB capture rate of 9% with LLL and 25% with SDL. A sample size of 170 will be required for a type-1 error rate of 5% and power of 80%. Accounting for a dropout rate of 20%, a total of 210 patients will be recruited (105 per group). Eligible subjects will be randomised to either the LLL or the SDL arm. The randomisation list will be generated with a computer-generated sequence in permuted blocks of 4, stratified by centre, to ensure a final allocation ratio of 1:1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A target of 210 participants will be enrolled in this study consisting of two groups and randomised in a 1:1 fashion to either of two groups. Group 1: Fixed helix, lumenless pacing lead (FHL) Group 2: Extendable helix, stylet driven pacing lead (EHL)
| Arm | Type | Receives |
|---|---|---|
| Fixed helix, lumenless pacing lead (FHL) | Active comparator | Device: Fixed helix, lumenless pacing lead.Lumenless leads used are fixed helix pacing leads (SelectSecure 3830 pacing lead from Medtronic) during the LBBP procedure. |
| Extendable helix, stylet-driven leads (EHL) | Active comparator | Device: Extendable helix, stylet-driven pacing lead.Stylet-driven leads used are extendable helix pacing leads (Biotronik Solia S60 lead from Biotronik or Tendril STS pacing lead from St. Jude Medical) during the LBBP procedure. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Fulfil current indications for pacemaker therapy according to international guideline recommendations:
- Age ≥21 years old
- Able to provide informed consent
- Planned LBBP implantation
Key exclusion criteria (4 listed)
- Severe tricuspid regurgitation or previous tricuspid valve intervention requiring implantation of left ventricular lead in the coronary sinus.
- Unable to provide informed consent.
- Pregnant women.
- <21 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fixed helix, lumenless pacing lead.Patients will be randomised to the fixed helix, lumenless pacing lead design during LBBP implantation. | Device | Fixed helix, lumenless pacing lead (FHL) |
| Extendable helix, stylet-driven pacing lead.Patients will be randomised to the extendable helix, stylet-driven pacing lead design during LBBP implantation. | Device | Extendable helix, stylet-driven leads (EHL) |
Primary outcome
Incidence of loss of left bundle branch capture
Time frame: 12 months
Loss of LBB capture is defined as the absence of the terminal r/R' complex in V1 during initial threshold interrogations at high pacing outputs and the absence of transitions in paced QRS morphology with decreasing pacing outputs until loss of myocardial capture.
6 secondary outcomes
Incidence of acute lead failure
Time frame: 12 months
Serial changes in pacing thresholds (V)
Time frame: 12 months
Serial changes in R-wave amplitude (mV)
Time frame: 12 months
Serial changes in lead impedance (ohm)
Time frame: 12 months
Serial changes in QRS duration (ms)
Time frame: 12 months
Incidence of peri-procedural complications
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Derived from this study: PubMed 42429724Tan ESJ, Soh R, Lee JY, Yip A, Sim MA, Chan SP, Reymatias J, Boey E, Tan VH, Yeo C, Lim WY, Leong K, Yeo WT, Seow SC, Kojodjojo P. Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes: LEAD-LBBP Randomized Clinical Trial. JACC Clin Electrophysiol. 2026 Jun 27:S2405-500X(26)00556-6. doi: 10.1016/j.jacep.2026.06.008. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene Tan, MBBS principal investigator
NUHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed helix, lumenless pacing lead. and Extendable helix, stylet-driven pacing lead. in people with Pacemaker DDD, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of loss of left bundle branch capture (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06318130, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025; AzTrials last refreshed its copy on 6 Nov 2026.